Breast Cancer Clinical Trial

Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

Summary

This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer. The study will also aim to assess the safety of TOL2506 in men with HR+ breast cancer. The Screening Period will be conducted in two parts: 1) an abbreviated, initial screening where premenopausal status will be determined prior to neoadjuvant or adjuvant chemotherapy (if planned) and 2) the full screening assessment conducted after neoadjuvant or adjuvant chemotherapy (or for subjects who enter the study without having received chemotherapy). Following the Screening Period, eligible subjects will enter into the 48 week Treatment Period in 1 of 2 groups: those who will receive tamoxifen concurrently with TOL2506 or those who will initiate therapy with an AI (letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, upon confirmation that estradiol (E2) levels of < 20 pg/mL have been achieved. After Week 12, subjects will be allowed to switch from receiving an AI to receiving tamoxifen or from tamoxifen to AI at the discretion of the Investigator. However, a switch is not permitted 28 days prior to a dosing visit (eg, Week 24, 36, and 48 where a pre-dose blood sample for PK and PD analysis will be drawn). At the end of the Treatment Period, upon completion of the End of Study Visit (Visit 9, Week 48) subjects may be eligible to participate in a Safety Extension Study under a separate Protocol.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Female

Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial
Age 18 to 49, inclusive
Diagnosis of Stage I, II, or III HR+, HER2-negative breast cancer (ER>1% and/or, PR>1%, HER2-negative per ASCO CAP guidelines)
Is a candidate for endocrine therapy + ovarian suppression LH > 4 IU/L within 28 days prior to Day 1

Is premenopausal as defined by:

E2 > 30 pg/mL
follicle stimulating hormone (FSH) < 40 IU/L
regular menses (eg, menstrual cycle length of 21 to 35 days) Note: premenopausal status must be determined before neo/adjuvant chemotherapy in patients for which it is planned or prior to Day 1 in patients who did not have prior chemotherapy. If premenopausal status was not determined prior to chemotherapy, E2 and FSH must meet the above criteria when measured 2 weeks or more after the end of the final cycle of chemotherapy.

Exclusion Criteria:

Body mass index (BMI) < 18.00 kg/m2 or > 35.00 kg/m2
Breastfeeding
Life expectancy < 12 months
Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3

Unacceptable hepatic function as determined by any of the following:

Alanine aminotransferase (ALT) ≥ 2X upper limit of normal (ULN)
Aspartate aminotransferase (AST) ≥ 2X ULN
Bilirubin ≥ 2X ULN
Alkaline phosphatase ≥ 2X ULN
Severe hepatic impairment (Child-Pugh Class C)

Unacceptable renal function as determined by any of the following:

Creatinine ≥ 3X ULN
Creatinine clearance ≤ 30 mL/minute
Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean

History of significantly abnormal ECG or screening 12-lead ECG demonstrating any of the following:

HR > 100 BPM
QRS > 120 msec
QTc > 450 msec
PR > 220 msec
Prior (within 28 days prior to Day 1) and/or concomitant use of medications known to prolong the QT/QTc interval
Prior use of tamoxifen, other SERMs (eg, raloxifene) or antagonists (eg, fulvestrant), aromatase inhibitor, mammalian target of rapamycin (mTOR) inhibitors, or hormone replacement therapy within 3 months before breast cancer diagnosis
Concomitant use of anticancer mediations other than those specified for use by the protocol
Prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer
History of treatment for osteopenia/osteoporosis
Prior (within 6 months prior to Day 1) or current use of drugs known to increase bone mineral density (ie, bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab) or use of supplements known to increase bone mineral density (ie, calcitonin, fluoride, strontium) within 28 days prior to Day 1
Low trauma fracture(s) occurring within 12 months prior to subject's first visit (defined as a fracture that results from a fall from a standing height or less, excluding fingers, toes, face and skull)
Conditions that preclude bone mineral density measurement (lumbar spine/bilateral hip surgery with hardware in place, abdominal clips, umbilical ring [not willing to remove] or weight that exceeds the DEXA machine limitation)
Any other medical condition or serious illness, presence of a second malignancy under current treatment or follow-up, or the presence of clinically significant findings on the physical exam, laboratory testing, medical history (including conditions that may be associated with low bone mass), that in the opinion of the Investigator may interfere with trial conduct, subject safety, or interpretation of study results
Already receiving and/or previously received GnRH analogs within 1 year before breast cancer diagnosis
Psychiatric, addictive, or other disorders that would preclude study compliance

Use of medications that may impact subject safety and/or affect the PK of the drug and hormonal assessments including but not limited to:

Oral or transdermal hormonal therapy within 30 days prior to subject's first visit
Estrogen, progesterone, or androgens within 30 days prior to subject's first visit
Hormonal contraceptives within 30 days prior to subject's first visit
Medications known to result in clinically important decreases in bone mass taken within 6 months prior to subject's first visit
Known hypersensitivity, idiosyncratic, or allergic reactions to GnRH, GnRH agonist/analogs or to any of the components of the IP
Sexually active with a male partner and not willing to use non-hormonal contraceptive methods throughout the study
Is of childbearing potential with a positive serum pregnancy test at Screening or urine pregnancy test at Day 1
Exposure to any investigational agent within 30 days prior to the first dose of TOL2506

See contact information to obtain inclusion/exclusion criteria for males

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT04906395

Recruitment Status:

Recruiting

Sponsor:

Tolmar Inc.

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There are 36 Locations for this study

See Locations Near You

Marin Cancer Care, Inc
Greenbrae California, 94904, United States
Holy Cross Hospital - Bienes Cancer Center
Fort Lauderdale Florida, 33308, United States
Cancer Care Centers of Brevard, Inc.
Melbourne Florida, 32935, United States
BRCR Medical Cancer Center Inc.
Plantation Florida, 33322, United States
Mount Sinai Hospital
Chicago Illinois, 60608, United States
Oncology of Northshore
Rolling Meadows Illinois, 60008, United States
Northwestern Medicine Cancer Center
Warrenville Illinois, 60555, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Baptist Health Louisville
Louisville Kentucky, 40207, United States
Hematology Oncology Clinic
Baton Rouge Louisiana, 70809, United States
Maryland Oncology Hematology, P.A.
Glenn Dale Maryland, 20769, United States
University of Maryland, St. Joseph Medical Center, Cancer Institute
Towson Maryland, 21093, United States
Revive Research Institute, Inc.
Farmington Hills Michigan, 48334, United States
Revive Research Institute, Inc.
Sterling Heights Michigan, 48314, United States
Washington University School of Medicine, Center for Advanced Medicine
Saint Louis Missouri, 63110, United States
St. Vincent - Frontier Cancer Center
Billings Montana, 59102, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68114, United States
Montefiore - Einstein Center for Cancer Care at Montefiore Medical Park
Bronx New York, 10461, United States
Hematology Oncology Associates of Central New York, PC
East Syracuse New York, 13057, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Lankenau Medical Center
Wynnewood Pennsylvania, 19096, United States
MUSC Hollings Cancer Center- HCC
Charleston South Carolina, 29425, United States
Tennessee Oncology, PLLC
Chattanooga Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Texas Oncology-Austin
Austin Texas, 78731, United States
Texas Oncology- Dallas Presbyterian Hospital
Dallas Texas, 75231, United States
Texas Oncology- Flower Mound
Flower Mound Texas, 75028, United States
Oncology & Hematology of South Texas, PA
Laredo Texas, 78041, United States
Joe Arrington Cancer Research & Treatment Center
Lubbock Texas, 79410, United States
Texas Oncology- San Antonio
New Braunfels Texas, 78130, United States
Texas Oncology- Plano East
Plano Texas, 75075, United States
Texas Oncology- Northeast Texas
Tyler Texas, 75702, United States
Texas Oncology- Deke Slayton Cancer Center
Webster Texas, 77598, United States
Seattle Cancer Center Alliance
Seattle Washington, 98109, United States
FDI Clinical Research
San Juan , 00927, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT04906395

Recruitment Status:

Recruiting

Sponsor:


Tolmar Inc.

How clear is this clinincal trial information?

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